EPIC! FDA OKs Human Clinical Trials of Embryonic Stem Cell Therapy; Trials Now Underway

If there was ever an epic event in the annals of medicine that could change the treatment landscape ― the introduction of stem cell therapy has to be counted near the top.

FDA Approved Human Clinical Trials of Embryonic Stem Cell Therapy are Now Underway

Advanced Cell Technology Inc. (ACTC) $0.151 OTCBB

On November 22, (ACTC) announced that it had received FDA approval to begin treating patients as part of the company's Phase I/II Clinical Trial focusing on the treatment Stargardt's Disease, a form of juvenile macular degeneration. A week later, (ACTC) announced that it has filed an Investigational New Drug [IND] Application with the US Food and Drug Administration [FDA] to initiate a Phase I/II multicenter study using human embryonic stem cells.*

After many years trudging through the maze of scientific and bureaucratic headwinds necessary to bring human embryonic stem cell [hESC] therapy to human trials, the recent FDA approval to begin treating patients is a truly momentous event in the history of medicine. I'm reminded of the epic line sung out to the world back in 1846 when a surgeon, Professor John Warren (a previous naysayer), on seeing ether first successfully demonstrated as an anesthetic, exclaimed to the assembled scientists and doctors: “Gentlemen, this is no humbug.”

Where would we be without the development of anesthesia? Now, a medical breakthrough of far more astounding implications—the use of stem cells to treat a major cause of vision loss that has no cure—looms large.

It is believed by many researchers that stem cells could be one of the most promising and potentially profitable areas of biotechnology—indeed, that they will forever change the way medicine is practiced. These experts believe that medical science is on the brink of replacing tissue that has been diseased or damaged with viable and healthy new stem cell-generated tissue.

See stunning videos by a team of Johns Hopkins scientists of a once-paralyzed rat walking again. I'm including a link to videos of both before and after stem cell therapy as an example of the wonders of this treatment.  And now human treatment is underway! Do not miss this:

http://www.hopkinsmedicine.org/bin/s/i/Video1.wmv

http://www.hopkinsmedicine.org/bin/q/p/Video2.wmv

A stem cell primer: Embryonic stem cells are unspecialized “master” cells that can become any cell. They self-renew through cell division. Importantly, under certain conditions, they can be induced to develop into many different cell types, becoming cells with special functions such as a brain cells, blood cells, and cells of the beating heart muscle or the cells of the insulin-producing pancreas. They can serve as a sort of repair system for the body, capable in theory of dividing without limit to replenish other cells as long as the person or animal is still alive.

Let's keep in mind that the use of stem cells is now part of everyday treatment in certain types of cancer therapy, and many people are alive because of it.

Some history: Remember the bone marrow transplants from donor relatives used to replace bone marrow that had been depleted by cancer therapy?  Well, since 1986 umbilical cord stem cells have been safely and routinely used to replace bone marrow that had been depleted by cancer therapy. The key point here is that un-matched stem cells were (and are now) used in these situations. Since then, hundreds of thousands of these therapies have been carried out.

On October 11, 2010, Geron Corporation (GERN) announced the first-ever clinical trial of human embryonic stem cell-based therapy on a human patient.

* On November 30, 2010 Advanced Cell Technology, Inc. (ACTC) became the second company to announce that it has filed an Investigational New Drug [IND] Application with the US Food and Drug Administration [FDA] to initiate a study using human embryonic stem cells [hESC]. (ACTC) will initiate Phase I/II multicenter testing on humans using derived retinal pigment epithelial [RPE] cells to treat patients with Dry Age-Related Macular Degeneration [Dry AMD]. Dry AMD reportedly afflicts more than 30 million people worldwide; including an estimated 13-15 million Americans who face severe vision loss or slow progression of the disease. Approximately 10% of people 66 to 74 years of age will have findings of macular degeneration, and this prevalence increases to 30% in patients 75 to 85 years of age.http://www.advancedcell.com/news-and-media/press-releases/advanced-cell-technology-receives-fda-clearance-for-the-first-clinical-trial-using-embryonic-stem-cel/ 

Market cap comparisons:

Genron Corp (GERN) Market cap of $498 million

BioTime Inc. (BTX) Market cap $377 million

Advanced Cell Technology(ACTC) Market cap $164 million

This is unquestionably a compelling story to follow. There is truly phenomenal potential here both for humanity and for the shares ofAdvanced Cell Technology. It goes without saying that there is a mega market for their new breakthrough science. Bearing all this in mind, and seeing the very favorable Market-cap comparisons above, I believe the (ACTC) shares should now be evaluated in terms commensurate with these astonishing developments—therefore I am including (ACTC) as one of my Best Ideas for 2011.

To view two exceptional PowerPoint presentations from (ACTC) link:

http://www.thechairmansblog.com/william-caldwell/wp-content/uploads/2010/12/Executive-Summary-ACT-Macular-Degeneartion-Program.pdf

http://www.thechairmansblog.com/william-caldwell/wp-content/uploads/2010/12/ACT-Macular-Degeneration-Program.pdf